Helicobacter Pylori InfectionNCT06382493
Tegoprazan-containing Sequential for H. Pylori
A study testing Tegoprazan-containing sequential H. pylori eradication therapy and Esomeprazole-containing sequential H. pylori eradication therapy in people with Helicobacter Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Tegoprazan-containing sequential H. pylori eradication therapy and Esomeprazole-containing sequential H. pylori eradication therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2021to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)
Who cannot join
- congestive heart failure, NYHA III or IV
- end-stage renal disease
- alcoholics
- drug abusers
- pregnant or nursing women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Nayoung Kim, M.D.,Ph.D.
About this study
Official title: Efficacy of Tegoprazan-containing Sequential Therapy Compared to Proton Pump Inhibitor-based Eradication in South Korea, a Region With High Antimicrobial Resistance: A Prospective Randomized Single Tertiary Center Study
As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy
Read the detailed description
Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tegoprazan-containing sequential H. pylori eradication therapy, Esomeprazole-containing sequential H. pylori eradication therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan-containing sequential H. pylori eradication therapyDrug
tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy
Esomeprazole-containing sequential H. pylori eradication therapyDrug
Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy)
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole-containing sequential H. pylori eradication therapy (conventional method) | Active comparator | esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days. Receives: Drug: Esomeprazole-containing sequential H. pylori eradication therapy |
| Tegoprazan-containing sequential H. pylori eradication therapy (experimental method) | Experimental | tegoprazan (50 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days. Receives: Drug: Tegoprazan-containing sequential H. pylori eradication therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Efficacy of H. pylori eradication therapy. confirmed by negative UBT test
Measured: 2 or 3 month
Secondary outcomes (1)
Adverse events
any adverse events occured during or after intervention (eradication therapy)
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Feb 2021
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, Prof., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382493
- Sponsor's protocol ID
- B-2011-648-005
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JW, Kim N, Lee J, Jo SY, Lee DH. Efficacy of Tegoprazan-Containing Sequential Eradication Treatment Compared to Esomeprazole-Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study. Helicobacter. 2024 Sep-Oct;29(5):e13143. doi: 10.1111/hel.13143.
PubMed 39434634
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tegoprazan-containing Sequential Therapy Compared to Proton Pump Inhibitor-based Eradication in South Korea, a Region With High Antimicrobial Resistance: A Prospective Randomized Single Tertiary Center Study
- ClinicalTrials.gov ID
- NCT06382493
- Acronym / sponsor ID
- B-2011-648-005
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy
Detailed description
Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole-containing sequential H. pylori eradication therapy (conventional method) | Active comparator | Drug: Esomeprazole-containing sequential H. pylori eradication therapyesomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days. |
| Tegoprazan-containing sequential H. pylori eradication therapy (experimental method) | Experimental | Drug: Tegoprazan-containing sequential H. pylori eradication therapytegoprazan (50 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)
Key exclusion criteria (5 listed)
- congestive heart failure, NYHA III or IV
- end-stage renal disease
- alcoholics
- drug abusers
- pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tegoprazan-containing sequential H. pylori eradication therapytegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy | Drug | Tegoprazan-containing sequential H. pylori eradication therapy (experimental method) |
| Esomeprazole-containing sequential H. pylori eradication therapyEsomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy) | Drug | Esomeprazole-containing sequential H. pylori eradication therapy (conventional method) |
Primary outcome
Eradication rate
Time frame: 2 or 3 month
Efficacy of H. pylori eradication therapy. confirmed by negative UBT test
1 secondary outcome
Adverse events
Time frame: up to 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 39434634Lee JW, Kim N, Lee J, Jo SY, Lee DH. Efficacy of Tegoprazan-Containing Sequential Eradication Treatment Compared to Esomeprazole-Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study. Helicobacter. 2024 Sep-Oct;29(5):e13143. doi: 10.1111/hel.13143.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nayoung Kim, Prof. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegoprazan-containing sequential H. pylori eradication therapy and Esomeprazole-containing sequential H. pylori eradication therapy in people with Helicobacter Pylori Infection, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jungwon Lee, Dr. (821093567758, saludos@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: 2 or 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06382493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.